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Deputy EEA QPPV

  • Distans
  • Sverige
  • Engelska
  • Publicerad 09.09.26 16:07

Deputy EEA QPPV - Lead Pharmacovigilance Governance Across Europe Our client is seeking an experienced Deputy EEA Qualified Person for Pharmacovigilance (QPPV) to join a high-performing global Patient Safety function. This is a senior leadership opportunity for a medically or scientifically qualified Pharmacovigilance professional to play a critical role in maintaining regulatory compliance, supporting benefit-risk evaluation activities, and acting as deputy to the EEA QPPV across a diverse product portfolio. As Deputy EEA QPPV, you will help ensure the company's Pharmacovigilance system remains compliant with European and global regulatory requirements while providing strategic scientific leadership across safety governance activities. OverviewEmployment Type - ContractDuration - 6-9 months with a view to extendHours - Full-timeWorking Model - RemoteStart - ASAP Key ResponsibilitiesServe as the designated deputy to the EEA QPPV and fulfil QPPV responsibilities during periods of absence.Support oversight, maintenance, and continuous improvement of the Pharmacovigilance system in accordance with EU and global regulations.Contribute to benefit-risk evaluation and safety governance activities across marketed and investigational products.Review and provide scientific input to:EU Risk Management Plans (RMPs)PSURs/PBRERsDSURsPASS and PAES protocols, reports, and publicationsClinical overviews and scientific safety documentsSmPCs, DHPCs, investigator communications, renewal and variation documentationParticipate in signal management activities, including signal detection, evaluation, prioritisation, and escalation.Ensure timely and scientifically robust responses to Health Authority requests and regulatory inquiries.Support interactions with EMA and national Competent Authorities where required.Represent the QPPV Office in Safety Management Teams, Medical Review Groups, PRAC-related activities, and other governance forums.Contribute to Pharmacovigilance inspections, audits, CAPAs, procedural development, and compliance oversight.Act as an ambassador for Pharmacovigilance governance across the organisation.Collaborate closely with Regulatory Affairs, Quality, Clinical Development, Medical Affairs, and Manufacturing functions. Required ExperienceMD (or international equivalent), PharmD, or PhD with substantial Pharmacovigilance experience.Minimum 10 years' experience within the pharmaceutical industry.At least 5 years of Pharmacovigilance experience within regional and/or global environments.Strong experience supporting or leading activities within EEA Pharmacovigilance frameworks.Extensive knowledge of:EU Pharmacovigilance legislationGVP requirementsICH and CIOMS guidanceBenefit-risk assessment methodologiesExperience supporting Health Authority inspections and regulatory audits.Demonstrated expertise in:RMPsPSURs/PBRERsDSURsSignal managementRisk minimisation activitiesAggregate safety reporting Ideal CandidateThe successful candidate will be a highly credible Pharmacovigilance leader with exceptional scientific judgement, regulatory expertise, and stakeholder management skills. You will be comfortable operating in a complex global environment, influencing cross-functional teams, and making critical safety decisions that support patient wellbeing and regulatory compliance. You will bring:Strong leadership and communication skillsExcellent organisational and project management capabilitiesProven ability to manage complex safety issues and regulatory obligationsExperience working with senior stakeholders and multidisciplinary teamsStrong analytical and problem-solving skillsA collaborative approach combined with the confidence to challenge when necessary Why Apply?High-profile Deputy QPPV leadership roleSignificant influence on global Pharmacovigilance strategy and governanceBroad exposure to regulatory agencies and senior leadershipOpportunity to shape safety processes and drive continuous improvementWork within a highly visible and strategically important Patient Safety function Apply NowIf you are an experienced Pharmacovigilance professional with extensive EU regulatory knowledge and are looking for an opportunity to step into a highly strategic Deputy EEA QPPV position, we'd love to hear from you.